Direct Materials Sciences Specialist/Expert

About the role

The Pharma Technical Operations (PT) Global MSAT & Engineering (PTT) group modernizes technical operations to enable Roche to deliver medicines more quickly, efficiently, and reliably. The PTT Materials Science Technical Specialist/Expert provides technical leadership for material topics, implementing material-driven solutions across PT manufacturing and distribution networks that align with internal and external regulations. Leveraging manufacturing expertise, the Technical Expert applies material science and data-driven knowledge to solve complex problems, ensuring a robust and flexible supply chain for direct materials and supporting Product Health.

Responsibilities

• Utilize material science expertise and product technical knowledge to support the product portfolio and internal/external manufacturing network, ensuring manufacturing continuity and compliance with industry requirements.
• Apply working knowledge of drug substance (cell culture, purification, formulation), drug product (filling and/or packaging), and/or small molecule processes to drive fit-for-purpose material solutions for manufacturing sites.
• Assess the performance of manufacturing processes at a network and portfolio level, leading strategic improvements related to robustness, speed, efficiency, safety, and sustainability, with a focus on materials.
• Lead or participate in cross-functional teams to ensure network material standardization, address critical material issues, or develop, improve, and implement material-related business processes, including single-use technologies (technical design, technical drawings, etc.).
• Represent PT as the material technical lead to external stakeholders (e.g., suppliers), including technical visits and audits.
• Lead key projects related to technical material lifecycle management, standardization, and new material implementation, ensuring alignment with Product Health goals.
• Interact with site (e.g., local MSAT, Manufacturing, QC) or global (Procurement, Supplier Quality, PTD) functions to identify appropriate materials or support identification of alternate materials or second suppliers.
• Collaborate with Specification and Filing teams within the Direct Material Management department to identify and implement fit-for-purpose materials, applying process requirements to support regulatory compliance.
• Serve as a recognized material expert by actively participating in deviation triages or CAPAs (local and global) related to direct materials, ensuring timely and appropriate action.

Requirements

• BS/MS/PhD (preferably in Science or Engineering-related fields) with at least 4 years of experience in the pharmaceutical, biopharmaceutical, or medical device industry, or an equivalent combination of education and experience.
• Expertise in raw materials, including material science, critical attribute assessments, and specifications, with a strong track record in pharmaceutical manufacturing, focusing on drug product manufacturing.
• Strong background in designing, implementing, and using single-use materials for drug product aseptic filling (advantageous).
• Demonstrated project management skills with working knowledge of ICH guidelines, GMP operations, and health authority regulations.
• Ability to interpret and apply Roche Quality standards, ensuring compliance through effective use of Quality Systems such as CAPA, Change Management, and risk assessment tools.
• Strong quality mindset with meticulous attention to detail and a commitment to service excellence.

Less than 10% travel required.

Pay

The expected salary range for this position based on the primary location of California is $93,900 - $174,500. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

Benefits

This position qualifies for the benefits detailed at the provided link (Genentech benefits). Relocation benefits are not available for this posting.